EMA Backs Acalabrutinib for Orphan Status in 3 Indications

The European Medicines Agency has endorsed Acerta’s acalabrutinib for orphan drug status for the treatment of chronic lymphocytic leukemia, mantle cell lymphoma and lymphoplasmacytic lymphoma. The drug is a BTK inhibitor in Phase 2/3 trials for all three indications.

AstraZeneca purchased a majority stake in Acerta for $4 billion in December, and analysts viewed the orphan announcement as an endorsement of AZ’s decision to invest in the company.